President-elect Trump’s plans for his first 100 days in office include “cutting the red tape at the FDA” and “speed[ing] the approval of life-saving medications.” Here, we consider specific steps Trump could take–without or with Congressional approval.
Pharmaceutical stocks took a hit after President-elect Trump criticized the industry during his January 11, 2017 press conference. But he also expressed support for the domestic pharmaceutical industry. What is the Trump pharmaceutical policy? We attempt to read the tea leaves.
The U.S. Supreme Court has agreed to review some of the patent dispute resolution provisions of the Biologics Price Competition and Innovation Act (BPCIA). The Court granted certiorari in the dispute between Amgen and Sandoz, where the Federal Circuit decided that the biosimilar patent dance provisions are optional, but pre-marketing notice always is required.
As I have written previously, neither the statutes nor the regulations governing Inter Partes Review (IPR) require the party challenging the patent to have been charged with infringement, or even to establish any interest in practicing the claimed subject matter. While the USPTO Patent Trial and Appeal Board (PTAB) has not imposed any standing requirements on IPR petitioners, the January 9, 2017 Federal Circuit decision in Phigenix, Inc. v. Immunogen, Inc. shows that not every petitioner will have standing to appeal a PTAB IPR decision.
Read this article on Foley’s PTAB Trial Insights blog for a summary of the Phigenix decision on standing for IPR appeals, and a discussion of some of the issues it raises.
On December 29, 2016, the FDA issued guidance to assist applicants seeking FDA approval of a proposed biosimilar product under the Biologics Price Competition and Innovation Act of 2009 (BPCIA). To obtain such approval, an applicant must demonstrate that the proposed product is “biosimilar” to a reference biological product already approved by the FDA. The new biosimilar guidance provides information on how such a showing can be made.